Proxalutamide for COVID-19: real-time analysis of all 7 studies

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Database of all proxalutamide COVID-19 studies. Submit updates/corrections.


Jul 25	Early	Cadegiani et al., medRxiv, doi:10.1101/2021.07.24.21261047 (Preprint)		Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: an Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy (EAT) with Proxalutamide (The EAT-Proxa Biochemical AndroCoV-Trial)
	Details Analysis of data from two proxalutamide early treatment RCTs with 445 patients showing substantial improvements in immunologic, inflammatory, thrombotic, and oxygen markers, which may support the observed reduction in hospitalization.
Jul 25	Details Source PDF Early treatment study Early treatment study
	Cadegiani et al., medRxiv, doi:10.1101/2021.07.24.21261047 (Preprint)
	Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: an Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy (EAT) with Proxalutamide (The EAT-Proxa Biochemical AndroCoV-Trial)
	Analysis of data from two proxalutamide early treatment RCTs with 445 patients showing substantial improvements in immunologic, inflammatory, thrombotic, and oxygen markers, which may support the observed reduction in hospitalization. Cadegiani et al., 7/25/2021, preprint, 4 authors.
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Jul 16	News	Kintor Pharmaceutical News Release (News)	news	Kintor Pharmaceutical Receives Emergency Use Authorization for Proxalutamide for the Treatment of COVID-19 in Paraguay
	Details News release announcing that proxalutamide has been granted an emergency use authorization for COVID-19 in Paraguay.
Jul 16	Details Source PDF News News
	Kintor Pharmaceutical News Release (News)
	Kintor Pharmaceutical Receives Emergency Use Authorization for Proxalutamide for the Treatment of COVID-19 in Paraguay
	News release announcing that proxalutamide has been granted an emergency use authorization for COVID-19 in Paraguay. Kintor et al., 7/16/2021, preprint, 1 author.
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Jul 10	Early	Cadegiani et al., medRxiv, doi:10.1101/2021.07.06.21260086 (Preprint)	death, ↓63.4%, p=1.00	Proxalutamide (GT0918) Reduces the Rate of Hospitalization in mild-to-moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Two-Arm Parallel Trial
	Details RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment.
Jul 10	Details Source PDF Early treatment study Early treatment study
	Cadegiani et al., medRxiv, doi:10.1101/2021.07.06.21260086 (Preprint)
	Proxalutamide (GT0918) Reduces the Rate of Hospitalization in mild-to-moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Two-Arm Parallel Trial
	RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment. risk of death, 63.4% lower, RR 0.37, p = 1.00, treatment 0 of 75 (0.0%), control 1 of 102 (1.0%), continuity correction due to zero event. risk of mechanical ventilation, 89.7% lower, RR 0.10, p = 0.07, treatment 0 of 75 (0.0%), control 5 of 102 (4.9%), continuity correction due to zero event. risk of hospitalization, 85.7% lower, RR 0.14, p < 0.001, treatment 2 of 75 (2.7%), control 19 of 102 (18.6%). Cadegiani et al., 7/10/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 7 authors.
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Jul 2	Late	Zimerman et al., medRxiv, doi:10.1101/2021.06.28.21259661 (Preprint)		Proxalutamide (GT0918) Reduction of Mortality Rate in Hospitalized COVID-19 Patients Depends on Treatment Duration - an Exploratory Analysis of the Proxa-Rescue AndroCoV Trial
	Details Analysis of treatment duration in the Proxa-Rescue AndroCoV trial showing significantly higher mortality among patients that interrupted treatment with proxalutamide. NCT04728802.
Jul 2	Details Source PDF Late treatment study Late treatment study
	Zimerman et al., medRxiv, doi:10.1101/2021.06.28.21259661 (Preprint)
	Proxalutamide (GT0918) Reduction of Mortality Rate in Hospitalized COVID-19 Patients Depends on Treatment Duration - an Exploratory Analysis of the Proxa-Rescue AndroCoV Trial
	Analysis of treatment duration in the Proxa-Rescue AndroCoV trial showing significantly higher mortality among patients that interrupted treatment with proxalutamide. NCT04728802. Zimerman et al., 7/2/2021, preprint, 17 authors.
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Jul 1	Late	Medeiros et al., ResearchGate (Preprint)		Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial
	Details Analysis of radiological findings from the Proxa-Rescue AndroCoV trial showing that proxalutamide significantly improves lung opacities compared to placebo. NCT04728802.
Jul 1	Details Source PDF Late treatment study Late treatment study
	Medeiros et al., ResearchGate (Preprint)
	Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial
	Analysis of radiological findings from the Proxa-Rescue AndroCoV trial showing that proxalutamide significantly improves lung opacities compared to placebo. NCT04728802. Medeiros et al., 7/1/2021, preprint, 23 authors.
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Mar 10	Late	Cadegiani et al., medRxiv, doi:10.1101/2021.06.22.21259318 (results 3/10/21) (Preprint)	death, ↓84.0%, p<0.0001	Efficacy of Proxalutamide in Hospitalized COVID-19 Patients: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Clinical Trial
	Details RCT 645 hospitalized patients, 317 treated with proxalutamide, showing significantly lower mortality and faster recovery with treatment. NCT04728802.
Mar 10	Details Source PDF Late treatment study Late treatment study
	Cadegiani et al., medRxiv, doi:10.1101/2021.06.22.21259318 (results 3/10/21) (Preprint)
	Efficacy of Proxalutamide in Hospitalized COVID-19 Patients: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Clinical Trial
	RCT 645 hospitalized patients, 317 treated with proxalutamide, showing significantly lower mortality and faster recovery with treatment. NCT04728802. risk of death, 84.0% lower, RR 0.16, p < 0.001, treatment 35 of 317 (11.0%), control 197 of 328 (60.1%), adjusted. risk of mechanical ventilation, 88.8% lower, RR 0.11, p < 0.001, treatment 4 of 317 (1.3%), control 37 of 328 (11.3%). risk of disease progression, 77.8% lower, RR 0.22, p < 0.001, treatment 36 of 317 (11.4%), control 168 of 328 (51.2%). risk of no recovery, 72.5% lower, RR 0.28, p < 0.001, treatment 46 of 317 (14.5%), control 173 of 328 (52.7%). recovery time, 50.0% lower, relative time 0.50, treatment 317, control 328. hospitalization time, 33.3% lower, relative time 0.67, treatment 317, control 328. Cadegiani et al., 3/10/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 30 authors.
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Feb 22	Early	Cadegiani et al., Cureus, doi:10.7759/cureus.13492 (Peer Reviewed)	viral+, ↓92.1%, p<0.0001	Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
	Details RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery.
Feb 22	Details Source PDF Early treatment study Early treatment study
	Cadegiani et al., Cureus, doi:10.7759/cureus.13492 (Peer Reviewed)
	Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
	RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery. risk of no virological cure, 92.1% lower, RR 0.08, p < 0.001, treatment 7 of 171 (4.1%), control 34 of 66 (51.5%), day 7, not including loss of taste or smell. risk of no recovery, 76.8% lower, RR 0.23, p < 0.001, treatment 30 of 171 (17.5%), control 50 of 66 (75.8%), day 7, including loss of taste or smell. recovery time, 85.0% lower, relative time 0.15, treatment 171, control 66, day 7, not including loss of taste or smell. recovery time, 80.7% lower, relative time 0.19, treatment 171, control 66, day 7, including loss of taste or smell. Cadegiani et al., 2/22/2021, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 8 authors.
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Dec 30 2020	Early	McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed)	death, ↓80.0%, p=0.50	Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
	Details RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429.
Dec 30 2020	Details Source PDF Early treatment study Early treatment study
	McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed)
	Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
	RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429. risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 134 (0.0%), control 2 of 134 (1.5%), continuity correction due to zero event. risk of mechanical ventilation, 97.1% lower, RR 0.03, p < 0.001, treatment 0 of 134 (0.0%), control 17 of 134 (12.7%), continuity correction due to zero event. risk of hospitalization, 91.0% lower, RR 0.09, p < 0.001, treatment 3 of 134 (2.2%), control 35 of 134 (26.1%). McCoy et al., 12/30/2020, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 15 authors.
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